8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Focus HD 43 Detector
FDA 510(k)
FDA Class 2
·Radiology
CD HORIZON VOYAGER SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POINT 4 TRANSLUCENT MODIFIED
FDA 510(k)
FDA Class 2
·Dental
ARTIS Q ZEEGO
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·December 10, 2024
WALLFLEX? ESOPHAGEAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code ESW·October 30, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 16, 2011
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 9, 2013
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017